Approval of regulations and specifications for new, improved veterinary preparations, feed additives

How to get the service in a state agency (required documents):

1. Statement. 
2. A document confirming the authority of the service recipient's representative (when the service recipient's representative applies).
3. 4 copies of regulations and specification in the official and Russian languages (for foreign applicants- notarized translation into official and Russian languages and copy of regulations and specification with copy of notarized translation) which includes:   

• standard 3 of organization and/or international standards.
• Instructions for the manufacture and control of a veterinary drug, feed additive, signed /approved by the developer or manufacturer of a veterinary drug, feed additive, containing information on the structure according to Annex 4 to the Rules.
• A manual (instruction) on the application (use) of a veterinary drug, a feed additive developed by the manufacturer, containing information on the structure according to Annex 5 to the Rules.
• A report on research work on the development, modification, improvement of a veterinary drug, feed additive (hereinafter referred to as the report on research work), as well as protocols (acts) of laboratory and production testing signed by the developer or manufacturer.
• For veterinary drugs used in the treatment, a report on research work, including information on pharmacokinetics, pharmacodynamics, toxicity (acute and chronic), teratogenicity and other necessary indicators of the active substance, drug stability, as well as reports/protocols/ acts on the study of the effectiveness and safety of a veterinary drug or its bioequivalence in the case of reproduced veterinary drugs.
• For vaccines, a report on research work, including information on the harmlessness, pathogenicity, biological activity, avirulence and other necessary indicators, stability of the drug, as well as reports / protocols / acts on the study of the effectiveness (duration and intensity of immunity) and biological safety of the veterinary drug.
• For feed additives and veterinary drugs used for disinfection, deratization and disinsection, a report on research work, including the results of efficiency tests.
• For veterinary drugs used for the diagnosis of diseases, a report on research work, including the results of tests of specificity, sensitivity, reproducibility.
• Passport for production and control strains of microorganisms and for transferable cell culture lines in accordance with Annex 6 to the Rules (for veterinary drugs created using microorganisms, components of their cells, products of life activities intended for the treatment, prevention and diagnosis of animal diseases).

4. A document confirming the registration of a veterinary drug, feed additive and/or entry into the state official pharmacopoeia of third countries, except for the member states of the Eurasian Economic Union (if any).
5. A notarized copy of the contract between the manufacturer and the patent holder of the components of a veterinary drug, feed additive, if there is a patent(s) for individual components of a veterinary drug, feed additive (strains of microorganisms used for the manufacture/ control of a veterinary drug, feed additive) or for the technology/method of manufacturing a veterinary drug, feed additive, or for its use/application.
6. A document confirming a permit to engage in activities for the production of veterinary drugs (for foreign manufacturers).

The service recipient, in addition to the documents, if available, submits documents certifying the production of veterinary drugs in accordance with the international standard: (Good manufacturing Practice (GMP)).

Documents drawn up in other languages are submitted with a notarized translation into the state and Russian languages.